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Upstream Development Team Leader

Upstream Development Team Leader

Job Title: Upstream Development Team Leader
Contract Type: Permanent
Location: Reykjavik
Industry:
Salary: TBD on application plus excellent benefits
Start Date: 2019-09-09
Reference: J45729 AB-1
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: September 10, 2019 07:33

Job Description

An exciting opportunity has arisen for an Upstream Development Team Leader. The company manufacture biosimilar monoclonal antibodies at their state-of-the-art facilities in Reykjavik, Iceland.
 
This company is well resourced and financed with significant growth plans. Be part of a company who has established itself as a fully integrated biopharmaceutical company, ranging from cell line development of biosimilars to manufacturing, clinical development and registrations. Their manufacturing process is based on 1,000L and 2,000L single use bioreactor fermentation design and has a total capacity of 16,000L and is run almost totally on renewable energy.  
As a team leader in upstream process development, you will be supervising a team of scientists and you are responsible for providing technical and scientific leadership and guidance to the USP development team to ensure efficient development and characterisation of an upstream process.
 
Job Responsibilities:
  • Write/ review/ approve appropriate SOPs, technical documents, reports and other GMP documentations
  • Support technology transfer with manufacturing (internal and external), scale up/down, troubleshooting and regulatory submissions
  • Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required
  • Maintaining leading-edge knowledge and understanding of new technologies in the field of USP process development and proactively share knowledge with the team
  • Ensure USP development labs and equipment are maintained in orderly fashion 
Qualifications:
  • Minimum of 5 years’ experience in biopharmaceuticals or technical field desired
  • Knowledge of upstream development activities (lab scale and production scale) including hands-on expertise operating upstream equipment
  • Demonstrated ability to lead, manage and motivate people and their activities
  • Experience with fed-batch and perfusion mode
  • Experience with screening experiments (Ambr or comparable)
  • Experience in harvesting techniques
  • Understanding of scale up / scale down 
Please forward your CV to Alex Butcher or phone 00 44 1403 216216 where we would be happy to tell you more about this exciting Upstream Development Team Lead opportunity.